FDA 510(k) Application Details - K133903

Device Classification Name Probe, Blood-Flow, Extravascular

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510(K) Number K133903
Device Name Probe, Blood-Flow, Extravascular
Applicant MEDTRONIC INC.
8200 Coral Sea Street NE
Mounds View, MN 55112 US
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Contact RAHUL SHAH
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Regulation Number 870.2120

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Classification Product Code DPT
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Date Received 12/20/2013
Decision Date 04/10/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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